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Approach to Technology Transfer
1.
2. Presentation Overview
1) Introduction 1 min
2) Vertical Take off 5 min
3) Process Transfers vs. Technology Transfers 10 min
4) Technology Transfer Deliverables 5 min
5) Application Techniques for Technology Transfer 35 min
6) Technology Transfer Skill Sets 10 min
7) Question Answer Session 10 min
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3. 1.0 Introduction - Robert Beall
Hometown: Syracuse, NY
Home: Columbus, OH
Family: Denise (Wife), Günther (Son)
Maren (Daughter),Calvin (Son), Olive(dog)
Hobbies: Sailing, Travel, Olympic Weightlifting
Education: RIT BS - Engineering
BI PMI – Ingelheim, Germany
Boehringer – Ingelheim Transfer Experience
1997-2000 BIRI -Columbus, OH Solids Transfer Engineer for Optimization in North America (OPINA)
2000-2007 BIRI Product transfers (Mobic, Spiriva, Micardis Plus) from (BIPKG) to USA (BIRI) .
2007–2010 BIPKG International transfer between Germany and India for WW distribution.
2010–2011 BVL Life-Cycle product transfer of parenteral manufacturing to new facility.
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3
4. 2. Technology Transfer Success
• Successful technology transfer will depend
on your ability to deploy these patterns of
success within your project organization
• The slides that follow describe a roadmap
you can follow to optimize your project
organization of technology transfer
5. 2. Typical Take-Off Curve
Performance
Process Go-Live
Secondary
Technology Development
(fixing issues)
Transfer
Time
• Typically, a newly transferred process experiences less than optimal performance at
the start. Like an out-of-tune biplane, the “take-off” is bumpy, experiencing ups and
downs at the start as the receiving team/site works out the kinks of the new process
and its technology. Performance ramps slowly over time, eventually achieving the
desired level of performance.
6. 2. The Concept of Vertical Take-Off
Performance
Process Go-Live
Secondary Development
Technology (fixing issues)
Transfer
Time
• The goal of any technology transfer should be to achieve the desired level of
performance quickly and smoothly. Like a jet, the new process “takes-off” at the
receiving site and delivers the desired heights of performance right from the start
(vertical take-off).
7. 2. The Value of Vertical Take-Off
Performance
Process Go-Live
Inefficiency
Rework
$
Low Yields
Waste Slow Speeds
Unplanned downtime
Technology Unclear roles
Transfer
Time
• There is a cost associated with most Technology Transfers that tends to stay hidden.
The slow, bumpy ramp-up to desired performance represents cash to the business in
the form of wastes, lower product yields , lost sales opportunities and slower return on
investment (ROI).
8. 3) Process transfers vs. Technology transfers
Process Transfer is the transfer of process information, or capability, associated
with process from a donor side (knowledge center) to a receptor side. The process is
learned and realized by both sides and complies all the regulatory requirements in
terms of Efficacy, Quality and Safety.
Technology Transfer, also called Transfer of Technology (TOT) is the process of
skill transferring, knowledge, technologies, methods of manufacturing, samples of
manufacturing to ensure that scientific and technological developments are
accessible to a wider range of users who can then further develop and exploit the
technology into new products, processes, applications, materials or services. It is
closely related to (and may arguably be considered a subset of) knowledge transfer.
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9. 3) Technology Transfers vs. Process Transfers
A) Process Transfer examples B) Technology Transfer examples
Bi-Layer tablet compression for FDC API manufacturing technology
DPI encapsulation NDA Product manufacturing
Gamma radiation sterilization for parenteral ANDA Product transfer
products
Includes: Includes:
Change control, Process Flow, URS, FDS, Process transfer plus- Strategic Plan,
IOQ, PQ, Cleaning validation, PV, Training, Validation master plan, Document
SOP’s matrix, Supply chain planning, Method
transfer, PDA, CPP,
OPINA SPIRIVA
- Two process train transfers every weekend - One transfer 5 years
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10. 3) Technology Transfers vs. Process Transfers
OPINA Process Transfer
Project Objective – Consolidate North American pharmaceutical processing in 1 plant
Special Boundaries- No stockpiling of inventory
Solution – Transfer two process trains and ancillary equipment every weekend for 5
weekends
Method – Dedicated transfer team developed plan for 6 months prior to execution.
- Process transfer was like for like.
- All non production transfer activities (training, utility installation, method
transfers, RM transfers, qualification documents completed prior to transfer.
- Minute by minute (micro) plan developed with video tape test runs.
- Easiest transfer first.
- Post mortem review of each process to fine tune for next transfer.
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11. 3) Technology Transfers vs. Process Transfers
SPIRIVA Technology Transfer
Project Objective – Create redundant US production facility for German blockbuster
Special Boundaries-Process not defined, 1 billion x18 µg capsule fill.
Solution – Mirror German implementation with 6 month lag.
Method – Dedicated team, Clear roles and responsibilities.
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12. 4) Technology Transfer Deliverables
In order to specify or to document the results of the technology transfer in a flexible
manner, a TTP or TTR could cover the technology transfer of one or all process steps 1).
Required documents detailing the technology transfer are listed in the Appendix of the
TTP or TTR.
One All
Technology Transfer Documentation Process Step Process Steps
Prepare Technology Transfer
Technology Transfer Protocol – Quality Control () 1)
Laboratory Qualification Report - Part 1 (TTLQ-Part1)
Checklist 'Laboratory Equipment‘ (CLLE)
Checklist 'Raw Material Specifications‘ (CLRMS)
Checklist 'Shipping‘ (CLS)
Technology Transfer Protocol – Production (TTPP) () 1)
Equivalency Report – Part 1 (TTEQ-Part1)
Checklist ‘Process Equipment‘ (CLPE)
Execute Technology Transfer
Technology Transfer Report – Quality Control () 1)
Laboratory Qualification Report - Part 2 (TTLQ-Part2)
Technology Transfer Report – Production (TTRP) () 1)
Equivalency Report – Part 2 (TTEQ-Part2)
13. 5) Application Techniques for Technology Transfers
9 Gate Technology Transfer Approach
Develop Process
Initial Customer
Project
Assessment 1 Review 2 Project 3 Mapped with
CPP
4
Plan
Opportunity Project Project Project
CPP with Gap
Recommendation Go Plan
Assessment
& Proposal Approved
Quality
Documents Eng. / Transfer
Complete Validation /
Batches Commercial
Quality Docs
Created 5 Batch
Prepare MFG
Execution 7 for
Validation
8 Validation.
batches
9
Production
Documents 6 Expansion Ready for Post-Approval
Completed
Documented Validation Assessment /
Ready for Post Mortem
Execution
Milestones assessed
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14. 5) Application Techniques for Technology Transfers
Gate 1. Project Charter -Scope of Transfer Process
Project Recommendation includes the following components:
1) Safety assessment
2) Quality assessment
3) Financial assessment
4) Overall Timeline
5) Framework for Technical Transfer Plan
6) Defines project boundaries – What is in scope, what is out of scope
7) Risks and Opportunities identified.
15. 5) Application Techniques for Technology Transfers
Gate 1. Project Recommendation -Scope of Transfer Process
The Master Documentation provides the framework for the transfer process. The Product Transfer Master Plan (PTMP) scope
document defines the boundaries of the transfer.
Specify ... Establish PTMP
• scope of transfer (process steps)
• technology transfer activities and documentation
• qualification & regulatory activities
• release as additional manufacturer
Product Transfer Master Plan’ (PTMP)
16. 5) Application Techniques for Technology Transfers
Gate 1. Gate 1. Project Recommendation –Know what you are
transferring.
Sending Site Process Receiving Site Process
P1 Stokes Mixer P2 Stokes Mixer P1 Stokes Mixer P2 Stokes Mixer
Add MCC, API, Dextrose Add MCC, API, Dextrose Add MCC, API, Dextrose Add MCC, API, Dextrose
and Starch, Mix for 5 min and Starch, Mix for 5 min and Starch, Mix for 5 min and Starch, Mix for 5 min
Pony Mixer Pony Mixer / Blend Cube
Add P1 and P2 Add P1 and P2
– Mix for 10 min – Mix for 10 min
Pony Mixer Pony Mixer / Blend Cube
Add Mag Stearate Study* Add Mag Stearate
– Mix for 5 min – Mix for 5 min
Poly Lined Drum SS Bin
Transfer Blend through #10 screen Transfer Blend through
#10 screen
Manesty Press Killian Press
Compress 25 mg tablets Study* Compress 10 mg tablets
• These processes have the same SUPAC classification per CDER
• This product transfer will be filed as a CBE – 30
17. 5) Application Techniques for Technology Transfers
Gate 1. Project Recommendation –Know what you are transferring
vs. Company Metrics
Product Design Attribute (PDA) TABLES
Comment
CTD Metric Most Favorable Less Favorable Least Favorable Critical #
P7 Number of Maximum 3 Maximum 6 Above 6 4
Worldwide (e.g. – one size clear blister of one
Primary material, one size opaque blister, 2 blister (7-ct push + 10-ct peel-
Packaging one size HDPE bottle) push)
Configurations 2 bottles 60mL + 120mL
The number of worldwide primary packaging configurations reported here is determined for each drug
product dosage form and strength.
Blister packaging configurations are determined by counting the different combinations of forming and
lidding materials being developed with consideration of the sealing area and perforations. Although the
number of tablets per blister is not considered when determining the number of worldwide primary
packaging configurations being developed, this aspect must be evaluated and taken into consideration
during capacity, transfer and launch planning by Operations.
Bottle packaging configurations are determined by counting the different combinations of bottles and
closures, with consideration of size, product count and materials.
P7 Packaging Standard HDPE bottle or standard Special moisture barrier packaging Special inert atmosphere and 2+
(Primary or PVC and/or PVDC blister suitable. needed (PVDC based materials oxygen barrier packaging
protective inadequate) or if hygroscopic required. Novel packaging
secondary or formulation prone to major failure materials required not
functional after HDPE bottle opened or failure commonly used for
having impact if bottle not reclosed in-use. pharmaceutical products.
on product Special light protective packaging Materials not approved for
quality) needed (lined bottles or dark glass). use in food or drug
Special design or configuration of packaging in US or EU.
HDPE bottles (e.g. desiccant),
Polypropylene bottle, or
Aluminum blister, bag, overwrap
required.
Multiple suppliers available. Only single supplier available but Single source supply with 5+
other suppliers can be developed. patent restrictions against
Blister foils: Alcan + Constantia Bottle: Gap last alternate suppliers.
18. 5) Application Techniques for Technology Transfers
Gate 2. Project Go
In order to support the documentation of the decision to execute technical
transfer the – Decision' template specifies format and content.
Technology Transfer Template
eRoom Folder:
1 Transfer Management
18/102 January 17, 2007
Handbook for Transfers of Chemical Products V02
19. 5) Application Techniques for Technology Transfers
Gate 3. Project Plan
The checklist 'Activities' (CLA) contains a proposal regarding activities which are in
principle relevant for a transfer. Relevant activities can be marked and copied to the
project plan.
Transfer of Chemical Product - Checklist 'Activites'
Process Step GL Activity Start Date End Date Resp. Rel.
Example
Set-up Transfer 2 Set up transfer project PL yes
Set-up Transfer 2 Set up eRoom PL yes
Set-up Transfer 2 Denominate transfer team PL yes
Set-up Transfer 2 Prepare kick-off meeting PL yes
Preparation of TTP 2 Idemtification of documents PM RU yes
Preparation of TTP 2 Preparation of documents PM SU yes
Preparation of TTP 2 Preparation of TTP - Quality Control QC SU yes
Acquisition and evaluation of the existing documentation on the synthetic
Preparation of TTP 2 P SU yes
method, including eventual batch records
Acquisition and evaluation of general documentation about ritical
Preparation of TTP 2 P SU yes
parameters or of a complete development report
Preparation of TTP 2 Check production needs and their compatibility with the actual planning P SU yes
Preparation of TTP 2
Feasibility analysis in plant on the existing documentation and lay-out
hypothesis of the process
P RU eRoom Folder:
yes
Preparation of TTP 2 Cost analysis on production hypothesis PM RU
1 Transfer Management
yes
Acquisition and evaluation of the safety documentation of the process,
Preparation of TTP 2 P RU yes
including MSDS
20. 5) Application Techniques for Technology Transfers
Gate 3. Project Plan
In order to specify the product transfer, the ‘Product Transfer Master Plan’ (PTMP)
template provides predefined structure, format and content.
Template
eRoom Folder:
2 Tech Transfer
21. 5) Application Techniques for Technology Transfers
Gate 3. Project Plan
MS Project serves as standard tool for the project planning of the product transfer. In
order to accelerate the preparation of the project plan, tasks from the activity list could
be pasted in.
Example
eRoom Folder:
1 Project Management
22. 5) Application Techniques for Technology Transfers
Conduct the
Pre-Use Flush
for the Closed
Solvent
Transfer
Gate 4. Process Flow
System
Sequential or
parallel?
1) Map production process with SME / Operators
2) Identify Critical Process Parameters (CPP) and Critical Ensure vent
bungholes on
both metal
waste drum and
Ensure proper
bonding and
grounding of
equipment.
Where
described
solvent drum
Quality Attributes (CQA) as they relate to finished are open
product not ok ok ok
not ok
3) Confirm all CPP / CQA have studies to support
acceptance ranges.
open them
Do I need to
4) Conduct studies to confirm CPP / CQA ranges to fill
contact
supervisor
first?
Attach Inlet
hose and Valve
No.2 of CST
system to the
gaps vessel and
record the
weight.
5) Determine best practice / gold standard process
6) Create CPP / CQA database (PANDA)
7) Compare CPP / CQA data values to “gold standard”
Calculate the
Calculate 95%
amount of
of total required
Dehydrated
Dehydrated
Alcohol,
Alcohol,
USP/EP/BP to
USP/EP/BP to
add to the
add to the
and ranges to determine cause of variance.
vessel via the is this
formulation
CST system correct?
vessel
(underfill?) confusing to
me..
8) Provide real time data trending to operators to enable Calculate 95%
educated process adjustment.
minus the
Underfill
Add this
amount to the
Continue agitation throughout solvent transfer
formulation
vessel.
Target transfer
weight of the
vessel achieved
Remove inlet
hose and Valve
No.2 from the
vessel and
record weight.
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23. 5) Application Techniques for Technology Transfers
Gate 4. CPP / CQA Matrix
Formulation Set Up Process Sub‐Step
Collect
Check Room Check Check Tank Equipment Attach Record
for Isolator for for and check for Pit Check Load Attach Isolator to Tare
Cleanliness Cleanliness Cleanliness Cleanliness Scale Isolator CST tank Wt
Visual, Visual Conf Set up
Logbook Mork sheet BOM ‐ Challenge Verify per SOP‐
Logbook confconf Alcohol Props / Calibration BOM Set up No breach Print tick
CQA Specification Visual Conf Visual Confrinse. clamp Verify cal Integrity per SOP alarms 0.5 kg
Clear, colorless to pale
yellow free from visable
Appearance Contamination 1 1 5 3 1 1 1 1 1
Volume Not less than 16.7 mL/Vial 1 1 1 1 1 1 1 1 1
Assay 98.0% ‐ 108.0% of label 1 3 3 3 3 1 1 1 5
pH 4.0 ‐ 6.0 1 1 3 3 1 1 1 1 1
Moisture NMT 0.6% 1 3 5 5 1 1 1 2 1
NMT 0.05 AU at A420 nm
Color of solution using ethyl alcohol blank 1 1 3 1 1 1 1 1 1
Ethanol 90% ‐ 110% of labeled amt 1 1 5 1 3 1 1 1 5
Paclitaxel Products NMT
0.1%
7 Epipaclitaxel NMT 0.3%
Limit of Total Degred Products NMT
Degredation 1.0% 1 1 2 4 1 1 1 1 4
Residual Solvents USP 467 1 1 1 1 1 1 1 1 1
NMT 0.67 EU/mg of
Microbe Testing Paclitaxel 3 3 5 3 1 3 1 2 1
NMT 6,000 parts > 10 micron
Particulate Matter NMT 600 parts > 25 micron 1 1 1 1 1 1 1 1 1
Based on ICH Q9 Guidelines
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24. 5) Application Techniques for Technology Transfers
Gate 5. QC Documents Completed
QC Documentation must be set prior to process transfer
Specify ... Establish PTMP
• scope of transfer (process steps)
• technology transfer activities and documentation
• qualification & regulatory activities
• release as additional manufacturer
Product Transfer Master Plan’ (PTMP)
Quality Control
Docs complete
25. 5) Application Techniques for Technology Transfers
Gate 5. QC Documents Completed
The technology transfer products starts with the qualification of the laboratory (QC
Transfer) and continues with the transfer of the manufacturing process (Production
Transfer). The equivalency check of the chemical product has to be performed by the
QC of the Sending Unit 1).
Production
Product
Receiving Unit
1st step:
2nd step: Qualification of laboratory
Equivalency check of (Parallel analysis of reference
product substance by SU and RU)
(Comparison of transfer batches
with reference batches)
Production Transfer
Product
Quality Control
Sending Unit
Transfer
Quality Control
Test Test
Sending Unit Receiving Unit
26. 5) Application Techniques for Technology Transfers
Gate 5. QC Documents Completed
The ‘Part 2’ of the ‘Technology Laboratory Qualification Report (TTLQ)’ template
supports to record the analytical results obtained in the parallel analysis by the RU, to
document the comparison of the results and the conclusions with regard to the
Example
fulfillment of the acceptance criteria.
TTLQ –P2
(TTRQC relevant part)
eRoom Folder: 3 Quality Control
27. 5) Application Techniques for Technology Transfers
Gate 6. Expansion Documents Completed
Specify ... Establish PTMP
• scope of transfer (process steps)
• technology transfer activities and documentation
• qualification & regulatory activities
• release as additional manufacturer
Product Transfer Master Plan’ (PTMP)
Quality Control Prepare
Docs complete Technology Transfer Docs
28. 5) Application Techniques for Technology Transfers
Gate 6. Expansion Documents Completed
The technology related part of the transfer is documented in technology transfer
documentation.
Technology Transfer – Quality Control Technology Transfer - Production
1) 4)
Specify scope of QC Transfer Prepare Specify scope of Production Transfer
Prepare
TT Protocol – Quality Control (TTPQC) Define Transfer Campaign Size
Check equivalence of laboratory TT Protocol – Production (TTPP)
CL ‘Laboratory Equipment (CLLE) Check equivalence of process
Check raw material specifications at CL ‘Process Equipment (CLPE)
CL ‘Raw Material Specifications’ (CLRMS) 5)
Specify equivalency check
Ship reference substances to RU TT ‘Equivalency Qualification–Part 1’ (TTEQ-P1)
CL ‘Shipping’ (CLS)
Specify qualification of RU laboratory
TT ‘Laboratory Qualification–Part 1’ (TTLQ-P1) Train manufacturing process at SU
Execute
Coach manufacturing process at RU
3)
Train analytical methods at SU Execute CE ‘Certificate Training – Production’ (CETP)
CE ‘Certificate Training – Quality Control’ Produce transfer campaign at RU
Execute parallel analysis at RU Execute equivalency check
TT ‘Laboratory Qualification–Part 2’ (TTLQ-P2)
TT ‘Equivalency Qualification–Part 2’ (TTEQ-P2)
Document results of QC Transfer Document results of Production
TT Report – Quality Control (TTRQC)
TT Report –Production (TTRP)
January 17, 2007
29. 5) Application Techniques for Technology Transfers
Gate 6. Expansion Equivalency Check
Knowledge
Range
Proven
Acceptable Range
Normal
Operating Range
Target Value
Parameter
Scale
30. 5) Application Techniques for Technology Transfers
Gate 6. Expansion Equivalency Check
The equivalency check has to be conducted for non critical parameters by min/max
comparison. EXAMPLE
Production SU Charts 1) have to Limit (USL) demonstrate
For critical parameters QC Upper Specification be usedProduction RU equivalency.
to
Upper Tolerance Limit (UTL) 2)
Measured
Value
Specification
+ 3 3)
Sample
Lower Tolerance Limit (LTL) 2)
No
Lower Specification Limit (LSL)
Remarks: 1) – upper or upper/lower limited control chart 2) Synonym: Upper/ Lower Control Limit; 3) 99,7% of the data should lie within the tolerance limits, the probability of a
false decision is 0,3% 30
Confidential
30/102
31. 5) Application Techniques for Technology Transfers
Gate 7. Expansion Completed
Specify ... Establish PTMP
• scope of transfer (process steps)
• technology transfer activities and documentation
• qualification & regulatory activities
• release as additional manufacturer
Product Transfer Master Plan’ (PTMP)
Quality Control Prepare Execute
Docs complete Technology Transfer Docs Regulatory Activities
Execute Expansion
Document ...
• results of technology transfer
• results of qualification and regulatory activities
• release as additional manufacturer
Product Transfer Master Report’ (PTMR)
34. 5) Application Techniques for Technology Transfers
Gate 9 Post Approval Assessment / Post Mortem
1. Review deliverables vs. plan
2. Review budget vs. plan
3. Review timeline vs. Base Plan
4. Revise templates accordingly.
37. Reference Sources
• *Sources:
• “Project Management Best-Practice Report”, APQC, 2004
• “A Guide to the Project Management Book of Knowledge®”, U.S. Department of Defense, 2003
• “European Technology Transfer Guide to Best Practice”, Teurpin, 2001
• “Benchmarking Best-Practices in Technology Transfer”, Colorado Institute for Technology Transfer
and Implementation, 1993
38. Conclusion
In Compliance
+
On Schedule
+
In Budget
=
SUCCESS !
ProPharma Group is the Best Choice
to balance all three needs!
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39. Product Design Attribute (PDA) TABLES
Comment
Critical at
CTD Metric Most Favorable Less Favorable Least Favorable
Milestone #
P7 Number of Maximum 3 Maximum 6 Above 6 4
Worldwide (e.g. – one size clear blister of one
Primary material, one size opaque blister, 2 blister (7-ct push + 10-ct peel-
Packaging one size HDPE bottle) push)
Configurations 2 bottles 60mL + 120mL
The number of worldwide primary packaging configurations reported here is determined for each drug
product dosage form and strength.
Blister packaging configurations are determined by counting the different combinations of forming and
lidding materials being developed with consideration of the sealing area and perforations. Although the
number of tablets per blister is not considered when determining the number of worldwide primary
packaging configurations being developed, this aspect must be evaluated and taken into consideration
during capacity, transfer and launch planning by Operations.
Bottle packaging configurations are determined by counting the different combinations of bottles and
closures, with consideration of size, product count and materials.
P7 Packaging Standard HDPE bottle or standard Special moisture barrier packaging Special inert atmosphere and 2+
(Primary or PVC and/or PVDC blister suitable. needed (PVDC based materials oxygen barrier packaging
protective inadequate) or if hygroscopic required. Novel packaging
secondary or formulation prone to major failure materials required not
functional after HDPE bottle opened or commonly used for
having impact failure if bottle not reclosed in-use. pharmaceutical products.
on product Special light protective packaging Materials not approved for
quality) needed (lined bottles or dark use in food or drug
glass). Special design or packaging in US or EU.
configuration of HDPE bottles
(e.g. desiccant), Polypropylene
bottle, or Aluminum blister, bag,
overwrap required.
Multiple suppliers available. Only single supplier available but Single source supply with 5+
other suppliers can be developed. patent restrictions against
Blisterfoils: Alcan + Constantia Bottle: Gaplast alternate suppliers.
Confidential 39
42. 3) Process transfers vs. Technology transfers
Trouble -
Typically both process transfers and technology transfer projects get into
trouble because:
1) Process was not “Right the first time” before the transfer.
2) Process technology was not up to date technology before transfer.
3) Resolve compliance issues during transfer.
Result – Extended timelines, cost overrun.
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43. Appendix A B CD
Appendix
9 Technology Transfer – Document Flow1)
9 Technology Transfer –
IChC Decision (FID)
Product Transfer
Master Plan’ (PTMP)
IChC decision on
Transfer of CP
Specify
transfer of CP
Document Flow
Technology Transfer
Protocol –QC (TTPQC)
QC Transfer
Specify scope of
Technology Transfer –QC Transfer –P
Production Transfer
Specify scope of Technology
roduction
Techn. Transfer Protocol
Checklist Laboratory Check equivalency –Production (TTPP )
Equipment (CLLE) of laboratory
Define Transfer Campaign
Size
Checklist Raw Material Check adequacy of raw
Specifications (CLRMS) material specifications RU/SU
Checklist Ship reference substances Check comparability of Checklist Process
Shipping (CLS) to RU process equipment Equipment
Laboratory Qualification Specify qualification
Report –Part 1 (TTLQ-P1) parameters (RU laboratory)
Specify equivalency Equivalency Report –
check Part 1 (TTEQ-P1)
Train analytical methods
at SU
Training Certificates
(CETQC)
Coach analytical methods at Train manufacturing
RU (optional) process at SU
Training Certificates
Laboratory Qualification Execute parallel analysis (CETP)
Report –Part 2 (TTLQ-P2) at RU Coach manufacturing
process at RU
Technology Transfer Document results of
Report –QC (TTRQC) Technology Transfer - QC
Produce transfer campaign
at RU
Equivalency Report –
Execute equivalency check Part 2 (TTEQ-P2)
Document results of Techn. Techn. Transfer Report
Transfer - Production –P roduction (TTRP )
Qualify CP
Execute Regulatory Activities
Product Transfer
Master Report’ (PTMR) Document transfer of CP
End
Remarks: CP –Chemical Product; 1) for more details please see Handbook
Handbook for Transfer of Chemical Products J 17, 2008
an
44. North to Phase V Product Transfers:
Project Phases / Responsibilities
GATE 1
GATE 2
GATE 3
GATE 4
44
45. North to Phase V Product Transfers:
Project Phases / Responsibilities
GATE 5
GATE 6
GATE 7
GATE 8
45
46. North to Phase V Product Transfers:
Project Phases / Responsibilities
GATE 9
46
48. Scope of Transfer Process (1)
The ‘Tech Transfer starts with a decision to transfer continues with the transfer of
(documented) knowledge, the demonstration of ability of the receiving unit to
manufacture the product to the satisfaction of all involved parties and ends with
successfully regulatory variations and the release as additional manufacturer.
Release as additional Manufacturer (End)
Tech Transfer
CRC Establish Product Transfer Master
Application Report
Execute regulatory activities ...
conceptual
Qualify API (by MP)
Execute Technology Transfer – Production
Equivalency of API MP Approval
Execute Technology Transfer – QC Laboratory Qualification 1)
Prepare Technology Transfer – Production
Prepare Technology Transfer – QC
Establish Product Transfer Master Plan
Manage project ...
IChC decision (Start) Time
Remarks: 1) Start of production of transfer batches; MP – Manufacturing Pharma; CRC – Change Review Committee; IChC – International
48/102 January 17, 2007
Chemicals Committee Handbook for Transfers of Chemical Products V02